Enteral feeding pump system

ABSTRACT

An enteral pump system for delivering medical fluids unidirectionally includes a disposable fluid delivery set having a repeatable compression portion and an enteral feeding pump. The repeatable compression portion is helically coiled around a central axis to define a cylindrical shape. The compression portion is configured to pump a large volume of medical fluids per stroke. The compressing portion includes at least two adjacent tubing walls joined around the central axis for repeatable compression. The enteral feeding pump is configured to repeatedly and reliably compress the compression portion of the fluid delivery set along the central axis. In operation, the compression portion is repeatably compressed without distortion along the central axis by the enteral feeding pump to flow unidirectionally through the fluid delivery set.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is related to and claims priority from earlier filedNon-provisional patent application Ser. No. 12/488,460 filed Jun. 19,2009 and earlier filed provisional patent application Ser. No.61/073,964 filed Jun. 19, 2008, the entire contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

The invention generally relates to enteral feeding systems, and inparticular enteral feeding pump systems. More specifically, theinvention relates to an enteral feeding pump system for deliveringmedical fluids unidirectionally including a disposable fluid deliveryset having a repeatable compression portion which is helically coiled todefine a cylindrical shape. The compression portion pumps a large volumeof medical fluids per stroke. Also, an enteral feeding pump configuredto repeatedly and reliably compress the compression portion of the fluiddelivery set along a central axis.

Enteral feeding pump systems are used to supply fluid nutrition topatients who are unable to eat. The pumping system consists of the pumpand disposable tubing sets. It is well known in the art that pumpingaction for an enteral feeding pump system has been primarily achieved byrotary peristaltic and linear peristaltic systems.

The rotary peristaltic system is a common approach that requires the useof a fluid delivery set having an elastomeric tubing segment in contactwith rotating rollers of a rotary peristaltic pump. The elastomerictubing segment is typically made of silicone rubber because of its gooddurability. The use of this material also requires transitional hardwareto connect to the lower cost PVC tubing of the fluid delivery set whichare used to convey the fluids from a source container to a patient. Thetubing segment made of silicone rubber and associated hardware addsignificant costs to the rotary peristaltic systems.

Another common enteral feeding pump system is a linear peristalticsystem. The linear peristaltic system requires tubing that is compressedin a series of platens. The tubing required for the linear peristalticpump is usually a higher grade (softer) PVC different from the low-gradePVC tubing used to convey fluid from a source container to a patient.The compression in the linear peristaltic system generates aunidirectional fluid flow that is controlled by the rate of thecompression steps. The pumped volume per stroke for this approach istypically very small so that a relatively large number of compressionsare required to meet flow demand and mechanical pumping components arestressed.

Therefore, there remains a need in the prior art for an enteral feedingpump system that provides for delivering medical fluids unidirectionallyincluding a disposable fluid delivery set having a repeatablecompression portion capable of pumping a large volume of fluids perstroke and an enteral feeding pump configured to repeatedly and reliablycompress the compression portion of the fluid delivery set along acentral axis. In addition, there is a need for compression in an enteralfeeding pump system using lower cost and, preferably, lower gradetubing. Also, there is a need for an enteral feeding pump system thatdoes not require transitional hardware to reduce the overall cost of theenteral pumping system. Also, there is a need for an enteral feedingsystem that requires less compressions to meet flow demand and does notstress other mechanical components.

BRIEF SUMMARY OF THE INVENTION

The invention preserves the advantages of prior enteral feeding pumpsystems. In addition, it provides new advantages not found in currentlyavailable enteral feeding pump systems and overcomes many disadvantagesof such currently available enteral feeding pump systems. The presentinvention provides an enteral feeding pump system for delivering medicalfluids unidirectionally including a disposable fluid delivery set havinga repeatable compression portion capable of pumping a large volume offluids per stroke and an enteral feeding pump configured to repeatedlyand reliably compress the compression portion of the fluid delivery setalong a central axis.

An enteral pump system for delivering medical fluids unidirectionallyincludes a disposable fluid delivery set having a repeatable compressionportion and an enteral feeding pump. The disposable fluid delivery setincluding a disposable tubing having a source end and a patient end usedfor providing nutritional fluids to a patient. In one embodiment, thedisposable tubing is a low grade tubing throughout its entire length.For example, the low grade tubing may be a low-grade PVC (polyvinylchloride) tubing or other inexpensive tubing approved for use in themedical field.

The compression portion is configured to pump a large volume of medicalfluids per stroke from a source end to a patient end relative to otherprior art enteral feeding pump systems. The repeatable compressionportion of the fluid delivery set is helically coiled to define acylindrical shape. The compressing portion includes at least twoadjacent tubing walls joined along a central axis for repeatable centralcompression. The adjacent tubing walls are joined at wall contact pointswhere at least two adjacent tubing walls meet at a central portion ofthe adjacent tubing walls. In one embodiment, the adjacent tubing wallsare joined at said wall contact points using a solvent material toprevent distortion of the compression portion during repeated centralcompression.

The disposable fluid delivery set including the compression portion ofthe tubing may be a spike set, bag set, or other configurations. Thespike set may include a spike member fluidly connected at the source endof the tubing, one or more roller clamp members positioned along saidtubing, and a patient fitting fluidly connected to the patient end. Thebag set may include a bag fluidly connected at the source end of thetubing, one or more roller clamp members positioned along the tubing, adrip chamber fluidly connected with the tubing near the bag, and apatient fitting fluidly connected to the patient end of the tubing.Other configurations or variations of the spike set and bag set may beused by adding or removing components to the fluid delivery set.

The enteral feeding pump is configured to repeatedly and reliablycompress the compression portion of the fluid delivery set along acentral axis. The enteral feeding pump including a housing, a pump motorunit disposed within the housing, a controller disposed within thehousing for directing the operation of the pump motor unit to provideselective sequential compression, a repeatable compression means forcompressing the compression portion of the fluid delivery set.

In one embodiment, the repeatable compression means includes a platesystem driven by the pump motor unit and disposed within the housing.The plate system includes a top plate respectively positioned to abottom plate. The top plate and the bottom plate configured to receivethe compression portion of a fluid delivery set. The top plateoperationally connected to the motor unit to move the top plate along anaxis towards the bottom plate.

The enteral feeding pump may also include a regulation means forregulating the flow of medical fluid into and out of the compressionportion of the fluid delivery set. In one embodiment, the means forregulating a flow of medical fluid are source end and patient endpinching mechanisms disposed within the housing and operationallyconnected to the pump motor unit. The source end pinching mechanismincludes first source end and second source end pinching members. Thefirst source end pinching member respectively positioned to the secondsource end pinching member. The first source end and second source endpinching members configured to receive a portion of a fluid delivery setbetween said source end of the fluid delivery set and the compressionportion of said fluid delivery set. The first source end pinchingmember, second source end pinching member, or both operationallyconnected to the motor unit to move the first source end pinching memberrelatively towards said second source end pinching member to regulatethe flow of fluid through the fluid delivery set from a fluid source.

The patient end pinching mechanism includes first patient end and secondpatient end pinching members. The first patient end pinching memberrespectively positioned to the second patient end pinching member. Thefirst patient end and second patient end pinching members configured toreceive a portion of the fluid delivery set between the patient end ofthe fluid delivery set and the compression portion of the fluid deliveryset. The first patient end pinching members operationally connected tothe motor unit to move the first patient end pinching member relativelytowards the second patient pinching members to regulate the flow offluid through the fluid delivery set and to the patient.

In another embodiment, the means for regulating a flow of medical fluidinto and out of the compression portion of the fluid delivery setincludes two or more valves connected at a patient end and source end ofthe fluid delivery set. For example, a source end one-way valve isfluidly connected between the source end and the compression portion ofthe fluid delivery set. In addition, a patient end one-way valve fluidlyconnected between the patient end and the compression portion of thefluid delivery set. The valves are preferably one-way valves or othervalves which allow fluid to flow unidirectionally.

In operation, the compression portion is repeatably compressed withoutdistortion along a central axis by the enteral feeding pump to flowfluid unidirectionally through the fluid delivery set using selectivesequential compression. For example, when the patient end pinchingmechanism is in an open position, the compression portion is compressedor stroked into a compression position to allow the fluid to flow out ofthe compression portion and through the patient end. Next, the patientend pinching mechanism is in a closed position and the source endpinching mechanism is in an open position. The compression portion thenrebounds from the compressed position to draw fluid through the sourceend and into the compression portion. Note, this selective sequentialcompression may be adjusted using different predetermined timingsequences to increase or decrease the desired flow rate and volume offluid delivered to the patient.

The invention also includes a method for flowing fluid unidirectionallyusing an enteral pumping system including a disposable fluid deliveryset and enteral feeding pump for delivery medical fluids. The methodincludes the following steps. First, a fluid delivery set is providedwhich includes a source end, a patient end, and the repeatablecompression portion. Second, the enteral feeding pump is provided forrepeatable compressing of the compression portion and regulating theflow of fluid into and out of the compression portion. Third, the fluiddelivery set is inserted into the enteral feeding pump. Fourth, therepeatable compression portion of the fluid delivery set is compressedusing the enteral feeding pump. Fifth, a regulating means closes theflow of medical fluid out of the compression portion and into thepatient end using the enteral feeding pump. Sixth, a regulating meansopens the flow of medical fluid into the compression portion from thesource end using the enteral feeding pump. Seventh, the compressedportion is released using the enteral feeding pump to allow medicalfluids to be drawn into the fluid delivery set through the regulatingmeans and into the compression portion from the source end. Eighth, theregulating means closes the flow of medical fluid into the compressionportion from the source end using the enteral feeding pump. Ninth, thecompressing portion is compressed by the enteral feeding pump to movemedical fluids out of the compression portion, through the regulatingmeans, and into the patient end. This process is continued dependingupon the flow rate and volume of liquid desired for a patient.

The present invention also includes a method of manufacture of arepeatable compression portion of a disposable fluid delivery set. Thecompression portion of a disposable fluid delivery set may be producedby the following steps. First, a disposable tubing is provided that isused for medical purposes. Second, the tubing is helically coiled arounda central axis to define a cylindrical shape. Third, the tubing istensioned during coiling to provide at least two adjacent tubing wallsaround the central axis for repeatable compression. Fourth, a dispensingsolvent is applied at wall contact points where at least two adjacenttubing walls meet at a central portion of said adjacent tubing walls tojoin adjacent tubing walls during coiling. Fifth, the tubing is coiledunder tension and joined by dispensing solvent to join adjacent tubingwalls until desired number of coil turns is reached to define acylindrical shape of the compression portion of the fluid delivery set.The number of turns for the compression portion is variable dependingupon the desire volume displaced upon a stroke.

The invention also includes a coiling apparatus for producing arepeatable compression portion of a disposable fluid delivery set. Thecoiling apparatus includes a spinning mandrel and a solvent dispenser.The mandrel and solvent dispenser having a power source, a motor unitfor turning the mandrel, a controller for directing the operation of themotor unit and controller, and a solvent source. The mandrel isconfigured for helically coiling a disposable tubing under controlledtension to produce a compression portion of the tubing defining acylindrical shape. The mandrel includes a retaining means for the tubingon the mandrel during coiling. A solvent dispenser is positioned nearsaid mandrel to contact the compression portion of the tubing. Thedispenser is in fluid connection with a solvent source. The dispenserproviding a solvent to join wall contact points of adjacent tubing wallsof the compression portion during helical coiling of the tubing.

In another embodiment, a repeatable compression portion of the tubingset may be formed in an alternative manner. A capture mechanism of anenteral feeding pump may provide a repeatable compression portion of thetubing set. The capture mechanism has a housing with one or moreapertures for initial receipt a straight or linear portion of the tubingset. A reeling mechanism is connected within the housing andoperationally connected to the enteral feeding pump for control ofoperations. The reeling mechanism has an inner area and an outer area.The reeling mechanism has one or more apertures within the outer areafor initial receipt of the portion of the tubing set. The inner areadefines a channel for receipt of the portion of the tubing set to securethe tubing set within the capture mechanism. The reeling mechanism isconfigured to rotate about an axis. When it rotates, the reelingmechanism provides the repeatable compression portion by helicallycoiling the portion of the tubing set about an central axis.

It is therefore an object of the invention to provide an enteral feedingpump system including a fluid delivery set and enteral feeding pump fordelivering fluid unidirectionally.

It is another object of the invention to provide a fluid delivery setincluding low-grade or inexpensive tubing that has a repeatablecompression portion.

It is another object of the invention to provide a spike set and bag setfor fluid delivery in enteral feeding that includes a repeatablecompression portion.

It is an object of the invention to provide the compression portion ofthe fluid delivery set which pumps a large volume of medical fluids perstroke.

It is yet another object of the invention to provide an enteral feedingpump configured to repeatedly and reliably compress the compressionportion of the fluid delivery set.

It is a further object of the invention to provide compression in anenteral feeding pump system using lower cost tubing.

Another object of the invention is to provide an enteral feeding pumpsystem that requires less hardware to reduce the overall cost of theenteral pumping system.

A further object of invention is to provide an enteral feeding pumpsystem that requires less compressions to meet flow demand and does notstress other mechanical components.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features which are characteristic of the present invention areset forth in the appended claims. However, the invention's preferredembodiments, together with further objects and attendant advantages,will be best understood by reference to the following detaileddescription taken in connection with the accompanying drawings in which:

FIG. 1 is a perspective view of a compression portion of a disposablefluid delivery set;

FIG. 2 is a plan view of a disposable fluid delivery set including acompression portion and a spike member;

FIG. 3 is a plan view of a disposable fluid delivery set including acompression portion and a bag;

FIG. 4 is a front view of an enteral feeding pump for delivering medicalfluids;

FIG. 5 is a block diagram of the operational components of the enteralfeeding pump of FIG. 4;

FIG. 6 is a front view of an enteral feeding pump system including anenteral feeding pump and disposable fluid delivery set including acompression portion;

FIG. 7 is a front view of a enteral feeding pump system including adisposable fluid delivery set including a compression portion andone-way valves;

FIG. 8 is a block diagram of a method for flowing fluid unidirectionallyusing an enteral pumping system including an enteral feeding pump anddisposable fluid delivery set having a compression portion;

FIG. 9 is a block diagram of a method of manufacturing a repeatablecompression portion of a disposable fluid delivery set;

FIG. 10 is a top view of a coiling apparatus for producing a repeatablecompression portion of a disposable fluid delivery set;

FIGS. 11A-11D are a sequence of side views of another embodimentincluding a disposable fluid delivery set having a portion insertedwithin a capture mechanism of an enteral feeding pump to provide acompression portion; and

FIGS. 12A-12D are respective sequence of top views of the embodiment ofFIGS. 11A-D showing the rotating of the portion of the tubing set withinthe capture mechanism to provide a compression portion.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the invention of FIGS. 1-10, the invention generallyrelates to enteral feeding systems, and in particular enteral feedingpump systems. More specifically, the invention relates to an enteralfeeding pump system for delivering medical fluids unidirectionallyincluding a disposable fluid delivery set having a repeatablecompression portion which is helically coiled to define a cylindricalshape. The compression portion pumps a large volume of medical fluidsper stroke. Also, an enteral feeding pump configured to repeatedly andreliably compress the compression portion of the fluid delivery setalong a central axis.

Referring to FIGS. 1-7, an enteral pump feeding system 60, 70 fordelivering medical fluids unidirectionally includes a disposable orreplaceable fluid delivery set 20, 30 having a repeatable compressionportion 10 and an enteral feeding pump 40. The disposable fluid deliveryset 20, 30 is configured for engaging with an enteral feeding pump 40.The disposable fluid delivery set 20, 30 including a disposable tubing21, 31 having a source end 21B, 31B for connection to a nutritionalsource and a patient end 21A, 31A for connection to a patient. Thedisposable tubing 21, 31 has a tubing wall and an area defined thereinfor the flow of fluid.

In one embodiment, the disposable tubing 21, 31 is a low grade tubingthroughout its entire length. For example, the low grade tubing may be alow-grade PVC (polyvinyl chloride) tubing or other inexpensive tubingapproved for use in the medical field. It should be noted that thisinvention is not limited to low-grade PVC tubing and that any tubingused in the medical field may be used, preferably inexpensive tubing.Low-grade PVC tubing is typically the standard tubing set used today inexisting enteral feeding pump systems. The use of the low-grade PVCtubing set saves additional costs over using more expensive higher gradePVC tubing sets, especially tubing sets using silicone portions.

The compression portion 10 is configured to repeatably pump a largevolume of medical fluids per stroke from a source end 21B, 31B to apatient end 21A, 31A. The compression portion 10 is durable and able toweather repeated compression over a longer period of time. Therepeatable compression portion 10 of the fluid delivery set 20, 30 ishelically coiled around a central C or vertical axis to define acylindrical shape. Of course, other shapes are capable of displacing alarge volume of fluid, such as coiled and spiral shapes. The compressingportion 10 includes at least two adjacent tubing walls joined or stackedaround a central axis C for repeatable axial compression along thecentral axis C. The adjacent tubing walls are joined at wall contactpoints 12 where at least two adjacent tubing walls meet at a centralportion of the adjacent tubing walls. In one embodiment, the adjacenttubing walls are joined at said wall contact points 12 using a solventmaterial to prevent distortion of the compression portion 10 duringrepeated compression.

The compression section 10 may have an adjustable number of coil turns.The number of coil turns, diameter of the tubing, and the diameter ofthe compression section is variable depending upon the desired volume ofliquid stroked or displaced, the flow rate, type of tubing material,durometer of the tubing material, viscosity of the fluid, and othercompression factors. For example, FIG. 1 illustrates a compressionsection 10 with seven coil turns. In another embodiment, the number ofcoil turns for the compression portion 10 may be seven with an innerdiameter of 25 mm for the compression portion 10. In another example,the number of coil for the compression section 10 may be nine with aninner diameter of 0.916 inches for the compression portion 10. These areonly examples and the number of coil turns and inner diameter may beadjusted according to desired characteristics discussed above.

Referring to FIGS. 2-3, the remainder of the fluid delivery set 20, 30at each end of the compression section 10 is used to connect to thefluid source and the patient. The remainder of the disposable fluiddelivery 20, 30 set may include a spike set 20, bag set 30, or otherconfigurations. The spike set 20 may include a spike member 22 fluidlyconnected at the source end 21B of the tubing 21, one or more rollerclamp members 24 positioned along the tubing 21, and a patient fitting26 with a cap 27 fluidly connected at the patient end 21A. The bag set30 may include a bag 32 fluidly connected at the source end 31B of thetubing 31, one or more roller clamp members 34 positioned along thetubing 31, a drip chamber (not shown) fluidly connected with the tubing31 near the bag 32, and a patient fitting 36 with a cap 37 fluidlyconnected to the patient end 31A of the tubing 31. Other configurationsor variations of the spike set 20 and bag set 30 may be used by addingor removing components to the fluid delivery sets 20, 30.

Referring to FIGS. 4-6, the enteral feeding pump 40 is configured torepeatedly and reliably compress the compression portion 10 of the fluiddelivery set 20, 30 along a central axis C. The enteral feeding pump 40including a housing 42, a pump motor unit 54 disposed within the housing42, a controller 52 disposed within the housing 42 for directing theoperation of the pump motor unit 54 to provide selective sequentialcompression, and a repeatable compression means for compressing thecompression portion 10 of the fluid delivery set 20, 30.

In one embodiment, the repeatable compression means includes a platesystem 44 driven by the pump motor unit 54 and disposed within thehousing 42. The plate system 44 includes a top plate 44A respectivelypositioned to a bottom plate 44B. The top plate 44A and the bottom plate44B configured to receive the compression portion 10 of a fluid deliveryset 20, 30 with an interior portion of the top plate 44A and bottomplate 44B. The top plate 44A are operationally connected to the pumpmotor unit 54 to axially move the top plate 44A towards the bottom plate44B.

The enteral feeding pump 40 may also include a regulation means forregulating the flow of medical fluid into and out of the compressionportion 10 of the fluid delivery set 20, 30. In one embodiment, themeans for regulating a flow of medical fluid are source end 46 andpatient end 48 pinching mechanisms disposed within the housing 42 andoperationally connected to the pump motor unit (not shown). The sourceend pinching mechanism 46 includes first source end 46A and secondsource end 46B pinching members. The first source end pinching member46A respectively positioned to the second source end pinching member46B. The first source end 46A and second source end pinching members 46Bconfigured to receive a portion of a fluid delivery set 20, 30 betweensaid source end 21B, 31B of the fluid delivery set 20, 30 and thecompression portion 10 of the fluid delivery set 20, 30. The firstsource end pinching member 46A, second source end pinching member 46B,or both are operationally connected to the motor unit (not shown) tomove the first source end pinching member 46A relatively towards saidsecond source end pinching member 46B to squeeze or apply pressure to aportion of the fluid deliver set 20, 30 to regulate the flow of fluidthrough the fluid delivery set 20, 30 from a fluid source.

The patient end pinching mechanism 48 includes first patient end 48A andsecond patient end pinching members 48B. The first patient end pinchingmember 48A respectively positioned to the second patient end pinchingmember 48B. The first patient end 48A and second patient end pinchingmembers 48B configured to receive a portion of the fluid delivery set20, 30 between the patient end 21A, 31A of the fluid delivery set 20, 30and the compression portion 10 of the fluid delivery set 10. The firstpatient end pinching member 48A, second patient end pinching member 48B,or both operationally connected to the pump motor unit 54 to move thefirst patient end pinching member 48A relatively towards the secondpatient pinching member 48B to squeeze or apply pressure to a portion ofthe fluid delivery set 20, 30, which regulates the flow of fluid throughthe fluid delivery set 20, 30 and to the patient.

When the pinching members 46A, 46B, 48A, 48B apply enough pressure whenengaging a portion of the fluid delivery set 20, 30, the flow of liquidis “pinched off” to prevent the flow of fluid through either the patientend 21A, 31A, source end 21B, 31B, or both. This is called a closedposition. When the pinching members 46A, 46B, 48A, 48B reduce oreliminate the pressure on the portion of the fluid delivery set 20, 30,the flow of liquid is allowed to return through either the patient end21A, 31A, source end 21B, 31B, or both. This is called an open position.

Referring to FIG. 5, a block diagram 50 depicts the key components ofthe enteral feeding pump 40. A controller 52 is in electricalcommunication with the pump motor unit 54 to direct the selectivesequential compression. The pump motor 54 is operationally connectedwith the plate system 57 and the pinching mechanisms 58, 59. Upondirection from the controller 52, the pump motor 54 drives the platesystem 57, source end pinching mechanism 58, and patient end pinchingmechanism 59 in selective sequential compression described furtherherein to provide unidirectional flow of liquid through a fluid deliveryset 20, 30. The controller 52, pump motor 54, and power source 56 andmethods of communication therebetween are known in the art.

In another embodiment, the means for regulating a flow of medical fluidinto and out of the compression portion 10 of the fluid delivery set 20,30 includes two or more valves 72, 74 fluidly connected at a patient end21A, 31A and source end 21B, 31B of the fluid delivery set 20, 30. Forexample, a source end one-way valve 74 is fluidly connected between thesource end 21B, 31B and the compression portion 10 of the fluid deliveryset 20, 30. In addition, a patient end one-way valve 72 fluidlyconnected between the patient end 21A, 31A and the compression portion10 of the fluid delivery set 20, 30. The valves 72, 74 are preferablyone-way valves or other valves which in combination allow fluid to flowunidirectionally.

In operation, the compression portion 10 is repeatably compressedwithout distortion along a central axis C by the enteral feeding pump 40to flow fluid unidirectionally through the fluid delivery set 20, 30using selective sequential compression. In one embodiment using thepinching mechanisms 46, 48, when the patient end pinching mechanism 48is in an open position, the compression portion 10 is compressed orstroked into a compression position to allow the fluid to flow out ofthe compression portion 10 and through the patient end 21A, 31A. Next,the patient end pinching mechanism 48 is placed in a closed position andthe source end pinching mechanism 46 is placed in an open position. Thecompression portion 10 then rebounds from the compressed position todraw fluid through the source end 21B, 31B and into the compressionportion 10. The amount of rebound is a function of the tubing grade,quality and the degree of tubing compression characteristics. Note, thisselective sequential compression may be adjusted using differentpredetermined timing sequences to increase or decrease the desired flowrate and volume of fluid delivered to the patient.

Another means to create directed flow is to use the patient end andsource end pinching mechanisms 46, 48 in the remaining uncoiled tubing21, 31 near both ends of the compressed portion 10. The two pinchingmechanisms 46, 48 alternately open and close in concert, or selectivesequential compression, with the compression portion cycles. Thefollowing sequence produces unidirectional flow:

-   0) patient pinch mechanism close-   1) source pinch mechanism open-   2) compressing portion release-   3) source pinch mechanism close-   4) compressing portion compress-   5) patient pinch mechanism close-   6) source pinch mechanism open-   7) compressing portion release-   8) source pinch mechanism close-   9) patient pinch mechanism open . . . etc

Fluid flow may be also directed by the inclusion of one way valves 72,74 in the remaining uncoiled tubing 21, 31 near both ends of thecompression portion 10. With a series of compressions and releases,fluid alternately forces one valve to open and another valve to close.The result is unidirectional flow. In operation, the compressing portion10 moves along a central C or vertical axis for fluid to flowunidirectionally within the fluid delivery set 20, 30, when thecompressing portion 30 is in a compressed position, the fluid is forcedout of the fluid delivery set through a first valve 72 at the patientend, when the compressed portion 10 rebounds from the compressedposition, fluid is drawn into the fluid delivery set through a secondvalve 74 at the source end.

The invention also includes a method for flowing fluid unidirectionallyusing an enteral pumping system including a disposable fluid deliveryset and enteral feeding pump for delivery medical fluids 80. The methodincludes the following steps. First, a fluid delivery set is providedwhich includes a source end, a patient end, and the repeatablecompression portion 82. Second, the enteral feeding pump is provided forrepeatable compressing of the compression portion and regulating theflow of fluid into and out of the compression portion 84. Third, thefluid delivery set is inserted into the enteral feeding pump 86. In oneembodiment, the fluid delivery set is color coded to mark theorientation of the compression portion within the enteral feeding pump.Fourth, the repeatable compression portion of the fluid delivery set iscompressed using the enteral feeding pump 88. Fifth, a regulating meanscloses the flow of medical fluid out of the compression portion and intothe patient end using the enteral feeding pump 89. Sixth, a regulatingmeans opens the flow of medical fluid into the compression portion fromthe source end using the enteral feeding pump 90. Seventh, thecompressed portion is released using the enteral feeding pump to allowmedical fluids to be drawn into the fluid delivery set through theregulating means and into the compression portion from the source end92. Eighth, the regulating means closes the flow of medical fluid intothe compression portion from the source end using the enteral feedingpump 94. Ninth, the compressing portion is compressed by the enteralfeeding pump to move medical fluids out of the compression portion,through the regulating means, and into the patient end 96. This processis continued depending upon the flow rate and volume of liquid desiredfor a patient.

In another embodiment, the invention also may provide a method for fluidflowing unidirectionally using the enteral feeding pump system. First,the method provides an enteral feeding pump system containingreplaceable low-grade PVC tubing set having a source end and a patientend. The source end is connected to a fluid source and the patient endis connected to a patient. The compression portion of the PVC tubing setis configured in a coiled or cylindrical shape. The PVC tubing is coiledto provide at least two tubing walls of the PVC tubing stacked along avertical axis. The tubing walls of the compressing portion are joinedtogether by solvent welding. The compressing portion fluidly connectedbetween the source end and the patient end. The first valve is connectedto the patient end and a second valve connected to the source end.Second, the valve is closed at the patient end. Third, the valve isopened at the source end. Fourth, the compressing portion is released toallow fluid to be drawn into the tubing set through the second valve atthe source end. Fifth, the valve at the source end is closed. Sixth, thecompressing portion is compressed to move fluid out of the tubing setthrough the first valve at the the patient end. Seventh, the valve isclosed at the patient end. Eighth, the valve is opened at the sourceend. It has consistent geometry and the method of bonding adjacent turnsresults in minimum impact on the compression characteristics of thecoil.

The present invention also includes a method of manufacture of arepeatable compression portion of a disposable fluid delivery set 100.The compression portion of a disposable fluid delivery set may beproduced by the following steps for solvent welding. First, a disposabletubing is provided that is used for medical purposes 102. Second, thetubing is helically coiled around a central axis to define a cylindricalshape. Third, the tubing is tensioned and properly pitched duringcoiling to provide at least two adjacent tubing walls around the centralaxis for repeatable compression 104. In one embodiment, the tension onthe tubing is provided by a weight of 250 gm and a pitch of 2.4coils/cm. This is merely an example of the weight and pitch that can beused. Fourth, a dispensing solvent is applied at wall contact pointswhere at least two adjacent tubing walls meet at a central portion ofsaid adjacent tubing walls to join adjacent tubing walls during coiling106. Fifth, the tubing is coiled under tension and joined by dispensingsolvent to join adjacent tubing walls until desired number of coil turnsis reached to define a cylindrical shape of the compression portion ofthe fluid delivery set 108. In an alternative embodiment, the solventmay be applied by dipping a compression portion in a solvent dippingbath to join the tubing walls together. The number of turns for thecompression portion is variable depending upon the desire volumedisplaced upon a stroke.

The invention also includes a coiling apparatus 110 for producing arepeatable compression portion 10 of a disposable fluid delivery set 20,30. The coiling apparatus includes a spinning mandrel 120 and a solventdispenser 140. The mandrel 120 and solvent dispenser 140 having a powersource, a motor unit for turning the mandrel, a controller for directingthe operation of the motor unit and controller, and a solvent source.The mandrel is configured for helically coiling a disposable tubingunder controlled tension to produce a compression portion 10 of thetubing defining a cylindrical shape. The mandrel 120 includes aretaining means 122 for the tubing on the mandrel during coiling. Asolvent dispenser 140 is positioned near said mandrel 120 to contact thecompression portion 10 of the tubing. The dispenser 140 is in fluidconnection with a solvent source. The dispenser 140 provides a solventto join wall contact points of adjacent tubing walls of the compressionportion 10 during helical coiling of the tubing. The production of thecompression portion 10 using the method and coiling apparatus 110 aboveresult in a consistent coil diameter which is critical. The end resultis compression portion which has coil turns bonded by the solvent weldeffect. The main advantage of this is there is no additional materialintroduced that could distort the compression characteristics of thecoil (as would occur if an adhesive were used).

The compression portion 10 is helically coiled around the central axisC. During engagement with the enteral feeding pump 40, the compressionportion 10 is stroked or displaced along the central axis C. As showngenerally in the FIGS. 1-10, the central axis C of the compressionportion 10 is defined as a vertical axis or oriented at a 90 degreeangle. However, it is contemplated that the central axis C of thecompression portion 10 may be defined as a horizontal axis or orientedat a 180 degree angle or somewhere in between. To accommodate thestroking of the compression portion 10 at a 180 degree angle or along ahorizontal axis, the enteral feeding pump 40 may have a plate system 44which is oriented along a horizontal axis and the top and bottom plates44A, 44B may include a retaining member or other means for seating thecompression portion 10 within the top and bottom plates 44A, 44B.

In view of the foregoing, a new and novel enteral feeding pump system60, 70 is provided which provides compression using a low cost tubingset for unidirectional flow of fluid. The enteral feeding pump system60, 70 meets flow demand while not stressing other mechanicalcomponents. Also, the enteral pumping system has low grade tubing, whichcosts less than high grade PVC tubing, and does not contain associatedhardware that adds cost to an enteral pumping system.

Referring to FIGS. 11A-D and 12A-D, in another embodiment, a repeatablecompression portion 10A of the tubing set or disposable fluid deliveryset 20A may be formed or created in-situ within the enteral feeding pumpsystem. It should be noted that the embodiment and method disclosed inFIGS. 11A-D and 12A-D incorporate the advantages and benefits of theembodiments described above and in FIGS. 1-10. In this embodiment, therepeatable compression portion 10A of the set may be formed or createdin-situ within a capture mechanism 200 of the enteral feeding pump usingthe tubing set 20A with a straight or linear portion of the tubing setwhich shall be described in more detail below.

The disposable fluid delivery set 20A for use with an enteral feedingpump to deliver medical fluids unidirectionally includes a disposabletubing used for medical purposes having a source end and a patient end.The tubing includes the repeatable compression portion 10A. Therepeatable compression 10A portion is helically coiled within thecapture mechanism 200 of an enteral feeding pump to define a cylindricalshape. The compression portion 10A is configured to pump a large volumeof medical fluids per stroke from a source end and to a patient end. Inone embodiment, the compression portion 10A includes at least twoadjacent tubing walls joined around a central axis C¹ for repeatablecompression.

The capture mechanism 200 of an enteral feeding pump may provide orcreate in-situ—the repeatable compression portion 10A of disposablefluid delivery set for use with an enteral feeding pump to delivermedical fluids unidirectionally. In one embodiment, the capturemechanism 200 has a housing 220 with one or more apertures 220A, 220Bfor initial receipt a straight or linear portion of the tubing set 20A.Of course, it is contemplated that the capture mechanism may have be aseparate component, with its own housing, or share a common housing orportion thereof of the enteral feeding pump system. A reeling mechanism210 is connected within the housing 220 and operationally connected tothe enteral feeding pump for control of operations. The enteral feedingpump used with the capture mechanism is similar to the enteral feedingpump described above.

The reeling mechanism 210 has an inner area and an outer area. Thereeling mechanism 210 has one or more apertures 210A, 210B within theouter area for initial receipt of the portion of the tubing set. Theinner area defines a channel 220 for receipt of the portion of thetubing set to secure the tubing set within the capture mechanism 200. Inone embodiment, the channel 220 extends entirely through the inner areaof the reeling mechanism 210 for receipt of sufficient portion of thetubing set to secure it therein. The reeling mechanism 210 is configuredto rotate about an axis C¹ with the tubing set therein. When it rotates,the reeling mechanism 210 provides the repeatable compression portion10A by helically coiling the portion of the tubing set about a centralaxis C¹ and forming the required compression portion in-situ.

The repeatable compression portion 10A of the tubing set for use inenteral feeding pumps may be prepared by the following steps. First, atube section, preferably linear or straight, of the tubing set isplaced, inserted, engaged, introduced or otherwise within the capturemechanism. The capture mechanism 200 is operationally connected to theenteral feeding pump. Of course, the tubing set maybe made of flexible,low-grade PVC tubing along its entire length or other types of materialssuited for enteral feeding. The straight, flexible tube section isterminated at each end by suitable connectors for a patient end and afluid end.

Next, the tube section is reeled, coiled, rotated or otherwise withinthe capture mechanism 200 around a central axis C¹ to provide ahelically coiled section defining a cylindrical shape and forming thecompression portion of the tubing set within the capture mechanism. Toremove the compression portion and the tubing set from the capturemechanism, the capture mechanism may be reverse its original direction.

Once the process of forming the compression portion 10A within thecapture mechanism 200 is complete, the enteral pump may reconfigureitself to produce oscillatory motion that would compress and release thecompression portion thus causing fluid flow. Of course, it iscontemplated that other means for compressing the compression portiondisclosed above, such as the plate system, may also be used inconjunction with the capture mechanism.

The capture mechanism 200 may be incorporated within the enteral pumpsystem which includes the disposable fluid delivery set, an enteralfeeding pump, and a means for a means for repeatable compressing of acompression portion of a fluid delivery set. In operation, thecompression portion repeatably compresses along a central axis for fluidto flow unidirectionally through the fluid delivery set. When thecompressing portion is in a compressed position, the fluid is forced outof the fluid delivery set through the patient end, and when thecompression portion rebounds from the compressed position, fluid isdrawn into the fluid delivery set through the source end.

Directional flow may be achieved by incorporating one-way valves in bothtubing connectors. The proximal connector 22A, connecting to the fluidsource, would have a low cracking pressure check or duck-bill valve. Thedistal connector 26A, connecting to the patient access tube, would haveanother one-way valve designed with a cracking pressure sufficient toprevent unwanted flow due to normal head pressure. Pressure produced bythe coil compression would exceed the cracking pressure and fluid wouldflow from the source container to the patient. Varying the oscillatoryperiod and/or stroke would allow for flow rate adjustment. Again, thecompression sequence for pumping using capture mechanism may be similarto the embodiments previously disclosed above.

The method of operation of the enteral feeding pump system incorporatingthe capture mechanism 200 may operate in accordance with the followingsteps but is merely an example and other methodologies of operationdiscussed above may be used. First, a fluid delivery set is providedhaving a source end and a patient end. Second, an enteral feeding pumpis provided for regulating the flow of fluid into and out of the fluiddelivery set. Third, a tube section of the tubing set made of low-gradePVC tubing is inserted within a capture mechanism operationallyconnected to an enteral feeding pump. Fourth, the tube section is reeledwithin the capture mechanism around a central axis to provide ahelically coiled repeatable compression section of the tubing set withinthe capture mechanism. The repeatable compression portion of said fluiddelivery set is compressed using the enteral feeding pump. A means forregulating the flow of medical fluid out of the compression portion andinto the patient end using the enteral feeding pump is closed. A meansfor regulating the flow of medical fluid into the compression portionfrom the source end using the enteral feeding pump is opened. Thecompressing portion is released using the enteral feeding pump to allowmedical fluids to be drawn into the fluid delivery set through the meansfor regulating the flow of medical fluid into the compression portionfrom the source end. The means for regulating the flow of medical fluidinto the compression portion from the source end using the enteralfeeding pump is closed. Next, the compressing portion is compressedusing the enteral feeding pump to move medical fluids through the meansfor regulating the flow of medical fluid out of the compression portionand into the patient end.

It would be appreciated by those skilled in the art that various changesand modifications can be made to the illustrated embodiments withoutdeparting from the spirit of the present invention. All suchmodifications and changes are intended to be within the scope of thepresent invention.

What is claimed is:
 1. An enteral pump system, comprising: a disposablefluid delivery set including: a disposable tubing used for medicalpurposes having a source end connected to a fluid source, the disposabletubing including a repeatable compression portion, and an enteralfeeding pump, including: a housing; a pump motor unit disposed withinthe housing configured for pumping medical fluids; and a controller fordirecting the operation of the pump motor unit, the controller havingopposing plates to provide selective oscillatory motion along a centralaxis to compress the repeatable compression portion of the disposabletubing set, said controller in electrical communication with said pumpmotor unit.
 2. The system of claim 1, further comprising: a capturemechanism to define a cylindrical shape retaining the repeatablecompression portion therein, wherein the repeatable compression portionis coiled around the central axis.
 3. The system of claim 2, wherein thecapture mechanism includes a reeling mechanism and a capture mechanismhousing, the reeling mechanism is mounted within the capture mechanismhousing for rotation about the central axis and connected to thedisposable tubing so that rotation of the reeling mechanism forms therepeatable compression portion in situ.
 4. The system of claim 3, thereeling mechanism configured to provide the repeatable compressionportion by helically coiling the portion of the tubing set about thecentral axis.
 5. The system of claim 3, wherein the opposing plates areoperationally connected to said pump motor unit, and the opposing platesare disposed within the housing.
 6. The system of claim 3, wherein thereeling mechanism has one or more apertures within an outer area forreceipt of the portion of the tubing set.
 7. The system of claim 6,wherein an inner area of the reeling mechanism defines a channel forreceipt of the portion of the tubing set to secure the tubing set withinthe capture mechanism.
 8. A method for flowing fluid, comprising:providing a fluid delivery set having a source end and a patient endwith a repeatable compression portion intermediate the ends, the fluiddelivery set comprising a disposable tubing set made of low-grade PVCtubing throughout its length; providing an enteral feeding pump forregulating the flow of fluid into and out of the fluid delivery set;compressing said repeatable compression portion made of low-grade PVCtubing of said fluid delivery set using the enteral feeding pump;selectively closing a first means for regulating the flow of medicalfluid out of the compression portion; selectively opening a second meansupstream of the repeatable compression portion for regulating the flowof medical fluid into the compression portion from the source end,wherein in a rebound position, the first means is closed and the secondmeans is open; and releasing the compression portion in the reboundposition to allow medical fluids to be drawn into the fluid delivery setfrom a source.
 9. The method of claim 8, further comprising: inserting atube section of the tubing set within a capture mechanism to provide ahelically coiled repeatable compression section of the tubing set. 10.The method of claim 9, further comprising: compressing the compressingportion using the enteral feeding pump to move medical fluids throughthe means for regulating the flow of medical fluid out of thecompression portion.
 11. The method of claim 9, further comprising:reeling in the tube section within the capture mechanism around acentral axis to provide a helically coiled repeatable compressionsection of the tubing set within the capture mechanism.
 12. The methodof claim 8, wherein in a delivery position, the first means is open andthe second means is closed; and further comprising the step ofcompressing the compression portion in the delivery position to egressthe medical fluids toward a patient.
 13. The method of claim 8, whereinthe first means and the second means are opposing pinching membersthrough which the disposable tubing set passes.